Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access

  • Global resolution secures patient access to Sandoz biosimilar Hyrimoz (adalimumab) for the reference medicine Humira **
  • Resolution paves way for 2018 launch in key European markets and secures US market entry planned in 2023

Holzkirchen, October 11, 2018 - Sandoz, a Novartis division and the global leader in biosimilars, today announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz (adalimumab) for reference medicine Humira ** (adalimumab).

"In order to realize the promise of early and expanded access and healthcare savings, biosimilars must be available as soon as possible to the patients and physicians who need them. This settlement helps remove uncertainty regarding when our biosimilar adalimumab will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz.

Under the terms of the agreement, AbbVie grants Sandoz a non-exclusive license to AbbVie’s intellectual property relating to Humira , beginning on certain dates in certain countries in which AbbVie has intellectual property. The license period will begin on October 16, 2018 in most countries in the European Union, and on other dates in various other countries outside the US where AbbVie has IP. In the US, the license period will begin on September 30, 2023.

Sandoz will pay royalties to AbbVie for licensing its Humira patents. All litigation pending between the parties will be dismissed. AbbVie will make no payments to Sandoz. The precise terms are confidential between the parties.

Sandoz biosimilar adalimumab was recently approved by the European Commission (EC) for the 31 countries of the European Economic area, which comprises the 28 member countries of the European Union plus Norway, Iceland and Liechtenstein. It is the seventh approved Sandoz biosimilar medicine.

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